BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIMA ACCEL PLT, PLS, RBC TUBING SET

    MDR report key: 2192475 · Received June 30, 2011

    Report

    Report Number
    1722028-2011-00193
    Event Type
    Malfunction
    Date Received
    June 30, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 2, 2011
    Manufacturer
    CARIDIANBCT
    Product Code
    LKN
    PMA / PMN Number
    BK100032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RUN DATA FILE WAS INVESTIGATED FOR THIS EVENT. SIGNALS IN THE RUN DATA FILE DO NOT INDICATE A CONCLUSIVE CAUSE FOR THE GREATER THAN EXPECTED RWBC CONTENT IN THE PLATELET PRODUCT REPORTED FOR THIS COLLECTION. NO UNUSUAL PROCESS VARIABLE WAS IDENTIFIED IN THE RUN DATA FILE AND THE TRIMA ACCEL SYSTEM OPERATED AS INTENDED. INVESTIGATION EVAL AND CORRECTIVE ACTIONS ARE IN-PROCESS. A F/U REPORT WILL BE PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER COULD LIKE THE RUN DATA FILE INVESTIGATED TO DETERMINE A POSSIBLE CAUSE FOR THE HIGHER THAN EXPECTED WBC CONTENT IN THE PLATELET PRODUCT. THE WBCS WERE COUNTED ON FLOW. THEY ALSO SAMPLED THE DAUGHTER BAGS TO SEE IF THE RESULTS ARE CONSISTENT WITH THE MOTHER BAG. NO MEDICAL INTERVENTION WAS REQUIRED FOR THIS EVENT. THE DISPOSABLE WAS DISCARDED BEFORE THE CUSTOMER IDENTIFIED THE COMPLAINT. THEREFORE IT IS NOT AVAILABLE FOR RETURN. PT WEIGHT IS UNAVAILABLE AT THIS TIME. (B)(4). THIS REPORT IS BEING FILED DUE TO DEVICE MALFUNCTION THAT HAS THE POTENTIAL FOR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIMA ACCEL PLT, PLS, RBC TUBING SET AUTOMATED BLOOD CELL SEPARATOR LKN CARIDIANBCT UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Other